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    Summary
    EudraCT Number:2016-004161-68
    Sponsor's Protocol Code Number:AG013-ODOM-201
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-004161-68
    A.3Full title of the trial
    A Phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of topically-applied AG013 for the attenuation of oral mucositis in subjects with cancers of the head and neck receiving concomitant chemoradiation therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Determination of Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day
    A.4.1Sponsor's protocol code numberAG013-ODOM-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03234465
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOragenics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOragenics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOragenics, Inc.
    B.5.2Functional name of contact pointCEO
    B.5.3 Address:
    B.5.3.1Street Address4902 Eisenhower Blvd, Suite 125
    B.5.3.2Town/ cityTampa, FL
    B.5.3.3Post code33634
    B.5.3.4CountryUnited States
    B.5.4Telephone number18132867900
    B.5.5Fax number18132867904
    B.5.6E-mailajoslyn@oragenics.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/11/903
    D.3 Description of the IMP
    D.3.2Product code AG013
    D.3.4Pharmaceutical form Mouthwash, powder for solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLACTOCOCCUS LACTIS SAGX0085
    D.3.9.2Current sponsor codeAG013
    D.3.9.4EV Substance CodeSUB72747
    D.3.10 Strength
    D.3.10.1Concentration unit billion CFU/ml billion colony forming units/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number13.3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberScientific recommendation ATMP (GTMP – not combined) on 18/02/2011. CAT Interactions refs: EMA/144334/2011 – EMA/CAT/837579/2010 and EMA/CAT/38889/2011 Annex C: Divergent positions
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboMouthwash, powder for solution
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Oral mucositis (OM) induced by chemoradiation therapy (CRT) used for the treatment of head and neck cancers (HNC)
    E.1.1.1Medical condition in easily understood language
    Oral mucositis (OM) caused by the treatment of head and neck cancers (HNC)
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028130
    E.1.2Term Mucositis oral
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -To evaluate the efficacy of topically administered AG013 compared to placebo for reducing OM in patients undergoing chemoradiation for the treatment of head and neck cancer, as measured by the duration, time to development, and overall incidence of OM during the active treatment phase, beginning from the start of chemoradiation therapy (CRT) until 2 weeks following its completion.
    -To determine the safety and tolerability of AG013 during the active treatment phase described above.
    E.2.2Secondary objectives of the trial
    -To evaluate the effect of AG013 on patient-reported symptoms and analgesic use during the active treatment phase, and on the cumulative radiation dose administered before the onset of OM.
    -To assess biomarkers and, in a subset of subjects, the PK profile of AG013.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx or unknown primary HPV-positive tumor presumed to be of oropharyngeal origin.
    -Tumor HPV status established
    -Planned to receive either primary or post-operative CRT
    -Planned IMRT (Intensity-Modulated Radiotherapy)
    -Planned administration of cisplatin administered weekly or tri-weekly during RT
    -Males or females 21 years or older
    -Karnofsky performance score (KPS) ≥ 70%
    -Screening laboratory assessments:
    Hemoglobin ≥ 10g/dl;
    White blood count ≥ 3500 cells/mm3;
    Absolute neutrophil counts ≥ 1500 cells/ mm3;
    Direct bilirubin ≤ 2x upper limit of normal (ULN);
    Serum AST and ALT ≤ 3 x ULN;
    Calculated Creatinine Clearance of 50 ml/min;
    Pregnancy test (serum or urine): negative for females of childbearing potential: a female is considered to be of child bearing potential unless she has had a tubal ligation or is postmenopausal (without a menstrual period for at least one year)
    E.4Principal exclusion criteria
    1.Prior radiation to the head and neck
    2.Presence of active infectious oral disease excluding oral candidiasis
    3.Presence of any oral lesions that may confound the ability to assess oral mucositis grade
    4.Current use of antibiotic rinses or troches
    5.Herbal, alternative remedies, and alcohol containing over-the-counter mouthwashes are excluded during the course of the study.
    6.Current alcohol abuse syndrome
    7.Chronic immunosuppression
    8.Known seropositive for HIV
    9.Use of investigational agent within 30 days of signing informed consent
    10.Tooth extraction prior to radiation
    11.Signs and symptoms of active dental disease
    12.Female subjects who are pregnant or nursing
    13.Any other clinical condition, psychiatric condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable or to comply with follow-up visits
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    -Duration (in days) of severe oral mucositis (WHO grades 3 or 4)

    Safety:
    -Incidence of adverse events, including serious adverse events (SAEs) and clinically significant laboratory abnormalities
    -Changes in vital signs and clinical laboratory parameters
    E.5.1.1Timepoint(s) of evaluation of this end point
    Duration of severe oral mucositis - evaluated twice weekly and on Day 14 post-CRT (end of active treatment phase visit)
    Incidence of AEs and SAEs - evaluated twice weekly during treatment, on Day 14 post-CRT, then weekly for 4 weeks after completion of active treatment
    Changes in vital signs and clinical laboratory parameters - evaluated weekly during treatment and on Day 14 post-CRT
    E.5.2Secondary end point(s)
    -Time to onset of severe oral mucositis (WHO grades 3 or 4)
    -Incidence of severe oral mucositis (WHO grades 3 and 4)
    -Duration of ulcerative oral mucositis (WHO grades 2, 3 or 4)
    -Time to onset of ulcerative oral mucositis (WHO grades 2, 3 or 4)
    -Incidence of ulcerative oral mucositis (WHO grades 2, 3 or 4)
    -Cumulative radiation dose to development of severe oral mucositis (WHO grades 3 or 4) and ulcerative oral mucositis (WHO grades 2-4)
    -Patient-reported pain as measured by Question 2 (mouth and throat soreness) of the Oral Mucositis Daily Questionnaire
    -Use of analgesics to control oral pain measured as morphine equivalents

    Pharmacokinetic and Pharmacodynamic:
    -Assessment of biomarkers (primarily pro- and anti-inflammatory cytokines)
    -PK profile of AG013 based on blood/serum samples and buccal smears in a subset of subjects



    E.5.2.1Timepoint(s) of evaluation of this end point
    All WHO grade secondary endpoints are evaluated twice weekly and on Day 14 post-CRT.

    Use of analgesics is evaluated twice weekly, on Day 14 post CRT, and weekly for 4 weeks after active treatment phase

    OM assessments will be completed at the screening and baseline visit, twice weekly (no less than 48 hours apart) within each 5-day RT during the active treatment phase, at the end of active treatment visit, and weekly for four weeks during the short term follow-up phase. If OM has not decreased to less than grade 2, weekly OM assessments will continue until OM is a grade 1 or less.

    Biomarkers are assessed at Baseline, Weeks 3 and 5 (on the last day of RT for that week), on Day 14 post-CRT, and at Week 2 of short term follow up phase
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-02
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